Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples (SAGE)

January 30, 2017 updated by: British Columbia Cancer Agency

Ex Vivo Gene Expression Profiling of Cervical Cancer Progression in Biopsies And Tissue Samples From Patients With Cervical Lesions

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial is studying gene expression profiling of cervical cancer progression in biopsies and tissue samples from patients with cervical lesions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Classify cervical cancer progression at a molecular level using gene expression profiling generated from expression microarrays.
  • Profile gene expression changes of dysplasia and early carcinoma of uterine cervical tissue at a molecular level using expression microarrays.
  • Define a set of genes that classify the various grades of cervical cancer/dysplasia at a molecular level.
  • Compare the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment.

OUTLINE: Patients undergo colposcopy and a cervical smear is taken for flow cytometry analysis. Patients also undergo 2 biopsies from one clinically abnormal or normal site. Tissue samples are analyzed by gene expression profiling using human expression microarrays containing approximately 40,000 unique sequences. Data analysis consists of defining a set of genes, containing new targets for biomarkers, that classify the biopsies into 3 grades.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L3
        • BC Cancer Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Clinically suspicious malignant or premalignant cervical lesion

Criteria

Inclusion criteria:

  • Included subjects will be ≥18 years old.
  • Included subjects will not be pregnant.
  • Included subjects will have a negative urine pregnancy test.
  • Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
  • Included subjects will indicate understanding of the study.
  • Included subjects will provide informed consent to participate.

Exclusion criteria:

  • Individuals <18 years old will be excluded.
  • Pregnant individuals will be excluded.
  • Individuals that have had an operation to remove their cervix will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Classification of cervical cancer progression at a molecular level using gene expression profiling
Gene expression changes by microarray
Set of genes that classify the various grades of cervical cancer/dysplasia
Comparison of the expression profiles of clinical data to determine how accurately cell lines model the in vivo environment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Thomas G Ehlen, M.D., BC Cancer Agency, Vancouver General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000581308
  • R01CA103830 (U.S. NIH Grant/Contract)
  • BCCR-H05-60100 (Other Identifier: UBC-BCCA REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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